DIN EN ISO 11979-6-2015 Ophthalmic implants - Intraocular lenses - Part 6 Shelf-life and transport stability testing (ISO 11979-6 2014) German version EN ISO 11979-6 2014《眼科植入物 眼内透.pdf

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1、February 2015 Translation by DIN-Sprachendienst.English price group 11No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I

2、CS 11.040.70!%?gU“2286850www.din.deDDIN EN ISO 11979-6Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014);English version EN ISO 11979-6:2014,English translation of DIN EN ISO 11979-6:2015-02Ophthalmische Implantate Intraokularlinsen Teil 6: H

3、altbarkeits- und Transportprfungen (ISO 11979-6:2014);Englische Fassung EN ISO 11979-6:2014,Englische bersetzung von DIN EN ISO 11979-6:2015-02Implants ophtalmiques Lentilles intraoculaires Partie 6: Dure de conservation et stabilit pendant le transport (ISO 11979-6:2014);Version anglaise EN ISO 119

4、79-6:2014,Traduction anglaise de DIN EN ISO 11979-6:2015-02SupersedesDIN EN ISO 11979-6:2007-11www.beuth.deDocument comprises 19 pagesIn case of doubt, the German-language original shall be considered authoritative.01.15 DIN EN ISO 11979-6:2015-02 2 A comma is used as the decimal marker. National fo

5、reword This document (ISO 11979-6:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (both secretariats are held by DIN, Germany). The responsible German body involved in its preparation was the DI

6、N-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-01-20 AA Intraokulare Medizinprodukte. DIN EN ISO 11979 consists of the following parts, under the general title Ophthalmic implants Intraocular lenses: Part 1: Vocabulary Part

7、 2: Optical properties and test methods Part 3: Mechanical properties and test methods Part 4: Labelling and information Part 5: Biocompatibility Part 6: Shelf-life and transport stability testing Part 7: Clinical investigations Part 8: Fundamental requirements Part 9: Multifocal intraocular lenses

8、Part 10: Phakic intraocular lenses The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 2248 DIN EN 22248 ISO 2233 DIN EN ISO 2233 ISO 8318 DIN EN ISO 8318 ISO 11979-1 DIN EN ISO 11979-1 ISO 10993-5 DIN EN ISO 10993-5 ISO 10993-12 DIN EN ISO

9、 10993-12 ISO 11607-1 DIN EN ISO 11607-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 14971 DIN EN ISO 14971 In Germany, use of the symbol “dpt” for dioptre (expressed in m1) is legally required and this symbol is to be used rather than the symbol D used in other countries. Amendments This standard differs fr

10、om DIN EN ISO 11979-6:2007-11 as follows: a) requirements and test methods for combined lens-injector systems have been included; b) the standard has been editorially revised; c) the text of ISO 11979-6:2014 has been adopted in its entirety. Previous editions DIN EN 13503-6:2003-03 DIN EN ISO 11979-

11、6:2007-11 DIN EN ISO 11979-6:2015-02 3 National Annex NA (informative) Bibliography DIN EN 22248, Packaging Complete, filled transport packages Vertical impact test by dropping DIN EN ISO 2233, Packaging Complete, filled transport packages and unit loads Conditioning for testing DIN EN ISO 8318, Pac

12、kaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency DIN EN ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity DIN EN ISO 10993-12, Biological evaluation of medical devices Part 12: Sample preparati

13、on and reference materials DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, se

14、aling and assembly processes DIN EN ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: Vocabulary DIN EN ISO 11979-2, Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methods DIN EN ISO 11979-3, Ophthalmic implants Intraocular lenses Part 3: Mechanical properties a

15、nd test methods DIN EN ISO 11979-4, Ophthalmic implants Intraocular lenses Part 4: Labelling and information DIN EN ISO 119795, Ophthalmic implants Intraocular lenses Part 5: Biocompatibility DIN EN ISO 119797, Ophthalmic implants Intraocular lenses Part 7: Clinical investigations DIN EN ISO 119798,

16、 Ophthalmic implants Intraocular lenses Part 8: Fundamental requirements DIN EN ISO 11979-9, Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses DIN EN ISO 11979-10, Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses DIN EN ISO 14971, Medical devices A

17、pplication of risk management to medical devices DIN EN ISO 11979-6:2015-02 4 This page is intentionally blank. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-6 October 2014 ICS 11.040.70 Supersedes EN ISO 11979-6:2007 English Version Ophthalmic implants Intraocular lenses Part 6: Sh

18、elf-life and transport stability testing (ISO 11979-6:2014) Implants ophtalmiques Lentilles intraoculaires Partie 6: Dure de conservation et stabilit pendant le transport (ISO 11979-6:2014) Ophthalmische Implantate Intraokularlinsen Teil 6: Haltbarkeits- und Transportprfungen (ISO 11979-6:2014) This

19、 European Standard was approved by CEN on 28 June 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

20、 concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN memb

21、er into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Fra

22、nce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES K

23、OMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11979-6:2014 E Contents PageForeword . 3Introduction 41 Scope . 52 Normative references 53

24、Terms and definitions . 54 Requirements 54.1 General . 54.2 Materials and methods 64.3 Product stability. 64.4 Package integrity . 84.5 Transport stability . 94.6 Results 95 Test methods and sampling 10Annex A (informative) Shelf-life study example . 11Annex B (informative) Tests for shelf-life stud

25、ies 14Bibliography 15DIN EN ISO 11979-6:2015-02 EN ISO 11979-6:2014 (E) 2Foreword This document (EN ISO 11979-6:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held b

26、y DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2015, and conflicting national standards shall be withdrawn at the latest by April 2015. Attention is drawn to the possibility that som

27、e of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11979-6:2007. According to the CEN-CENELEC Internal Regulations, the national standards organization

28、s of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

29、Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11979-6:2014 has been approved by CEN as EN ISO 11979-6:2014 without any modification. DIN EN ISO 11979-6:2015-02 EN ISO 11979-6:2014 (E)

30、3IntroductionThe purpose of a stability study is to ascertain that the properties of a product, in this case an intraocular lens (IOL), remain within specified limits for a sufficiently long period of time under the influence of a variety of environmental conditions.The storage stability of the intr

31、aocular lens material is an important factor in the overall investigation of a new lens material, a new combination of given lens materials, a new packaging material, or a new manufacturing process. To assess this, a study of the ageing of the lenses in their containers is performed.Changes in the c

32、omposition and material, material suppliers, manufacturing conditions (including the sterilization process), or the package design or material could affect the shelf-life and could therefore necessitate renewed investigations. The need for studies of product stability, package integrity, and transpo

33、rt stability can be assessed using ISO 14971.The design of the stability tests should be based on the known properties of the material from which the intraocular lens is made, and the recommendations for use of the intraocular lens. Knowledge of the quantity and identity of extractable substances fo

34、und after storage or accelerated ageing studies are of importance in evaluating new intraocular lens materials.On the basis of the information obtained, transport and storage conditions can be recommended that will maintain the quality of the intraocular lens in relation to its safety, efficacy, and

35、 acceptability, throughout the proposed shelf-life, i.e. during storage and distribution up until the moment of dispensing. The results obtained are also used to determine the expiration date.In practical terms, it is the stability of the material from which the intraocular lens is made that is bein

36、g tested, along with the integrity of the packaging that maintains the necessary environment of the intraocular lens.Stability studies for intraocular lenses are thus material specific, i.e. this type of study need not be performed for more than one intraocular lens model for a given combination of

37、IOL material(s), packaging materials, and manufacturing processes.DIN EN ISO 11979-6:2015-02 EN ISO 11979-6:2014 (E) 41 ScopeThis part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures

38、to establish the stability of IOLs in distribution and storage.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the

39、latest edition of the referenced document (including any amendments) applies.ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: VocabularyISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicityISO 10993-12, Biological evaluation of medical devices Part

40、12: Sample preparation and reference materialsISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming

41、, sealing and assembly processesISO 14971, Medical devices Application of risk management to medical devices3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 11979-1 apply.4 Requirements4.1 GeneralIf, following a risk analysis in accordance with ISO 149

42、71, it is found that a product stability study, a package integrity study, and/or a transport stability study are needed, this part of ISO 11979 shall apply to the planning and conduct of these studies.A study protocol shall be developed prior to initiation of the study.The study results shall demon

43、strate that the parameters measured with regard to performance, safety, and product acceptability are within the finished product specifications, when available. In cases where there are no finished product specifications, then the parameters measured shall remain within the limits of the applicable

44、 parts of ISO 11979. If there exists neither finished product specifications nor applicable limits specified within ISO 11979, then a comparison to time zero product shall be performed.DIN EN ISO 11979-6:2015-02 EN ISO 11979-6:2014 (E) 5In view of the fact that an intraocular lens may not have suffi

45、cient storage assessments accumulated by the time it is brought to the market, the results of accelerated tests (see 4.3.2) are acceptable for initial labelling purposes, i.e. to establish a shelf-life to be indicated on the product labelling. A maximum of five years of shelf-life can be claimed by

46、a real-time study or an accelerated study regardless of material used in the intraocular lens. However, an accelerated study shall always be verified by a real-time study, and the real-time study results shall always take precedence over the accelerated study results. The same product or a Level A m

47、odification of it (see ISO/TR 22979) shall be used in the real-time study, and the real-time study shall be started before the release of the new intraocular lens into the market.In case a manufacturer wishes to maintain the possibility of resterilizing finished intraocular lens lots, the finished i

48、ntraocular lens lot(s) used in the stability study shall have undergone the maximum number of sterilization cycles allowed under the manufacturers procedures.4.2 Materials and methods4.2.1 Test samplesThe studies shall be performed using IOLs from finished intraocular lens lots. The proposed sample sizes are described in Annex A.4.2.2 MethodsSuitable methods shall be chosen for any tests contained in the study protocol. The me